Biowave BiowavePRO User manual

user’s manual
Rx Only
Revised
Mar 2018
The BiowavePRO Neurostimulator
is used as part of the following
neuromodulation pain therapy
systems:
•biowavePRO
Professional Neuromodulation
Pain Therapy System
•biowavePENS
Percutaneous Electrical
Nerve Stimulation
Designed to Block Pain™
®

BiowavePRO®User’s Manual
Biowave Corporation
2Rev: 11 - 180201

Biowave Corporation 1
Table of Contents
1. Indications For Use ...........................................................................................7
2. Neurostimulator Description ...........................................................................8
2.1 Neurostimulator Accessories .................................................................................... 9
2.1.1 Leadwire Cable ...............................................................................................9
2.1.2 AC Charger ...................................................................................................11
2.2 Electrodes................................................................................................................ 12
2.2.1 Biowave Noninvasive Reusable Electrodes (BiowavePRO) ..........................13
2.2.2 Biowave Percutaneous Electrodes (BiowavePENS)......................................14
2.3 Neurostimulator Controls........................................................................................ 15
2.3.1 Power Button.................................................................................................15
2.3.2 Plus Button ....................................................................................................15
2.3.3 Minus Button.................................................................................................15
2.3.4 Time Button and OK Button.........................................................................15
2.4 Neurostimulator Indicators...................................................................................... 16
2.4.1 LCD Display...................................................................................................16
2.4.2 System Indicator Light ..................................................................................17
3. When the Neurostimulator Should Not Be Used (Contraindications),
Risks/Benefits, Warnings, Precautions and Adverse Reactions..................18
3.1 When the Neurostimulator Should Not Be Used (Contraindications).................... 18
3.2 Risks/Benefits .......................................................................................................... 19
3.2.1 Risks...............................................................................................................19
3.2.2 Benefits .........................................................................................................19
3.3 Warnings...................................................................................................................20
3.4 Precautions ...............................................................................................................21
3.5 Adverse Reactions....................................................................................................22
4. User Instructions .............................................................................................23
4.1 Set Up and Operating Instructions ..........................................................................23
4.2 Rationale for Electrode Placements .........................................................................24
4.3 Focusing of the Biowave Signals and Electrode Placement....................................25
4.4 Body Position During the Treatment........................................................................26
4.5 Motion During the Treatment and Fine Tuning of the Treatment ...........................27
(continued)

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4.6 Electrode Placement Examples for Noninvasive Electrodes ........................... 28
FOR PERCUTANEOUS ELECTRODE Placements, see BiowavePENS Quick
Reference Guide or call Technical Support at 1-877-BIOWAVE ext 2.
4.6.1 LOW BACK PAIN - ELECTRODE PLACEMENT EXAMPLES......................29
4.6.1.1 Placement for Bilateral Low Back Pain (Pain in 2 Locations)...............29
4.6.1.2 Placement for Radiculopathies.......................................................29
4.6.1.3 Placement for Sacroiliac (SI) Joint Pain...........................................30
4.6.1.4 Placement for Pain Centered Over the Spine................................30
4.6.1.5 Placement for Low Back Pain in One Location ..............................31
4.6.1.6 Placement for Pain Over a Large Area on the Back
(for example for pain from a rotational strain)................................32
4.6.2 HIP PAIN - ELECTRODE PLACEMENT EXAMPLES....................................33
4.6.2.1 Placement for Hip Pain in One Location ........................................33
4.6.2.2 Placement for Hip Pain in Two Locations
(for example for anterior and lateral hip pain) ...............................33
4.6.3 RIB OR OBLIQUE PAIN - ELECTRODE PLACEMENT EXAMPLES ............34
4.6.3.1 Placement for Rib or Oblique Pain in One Location......................34
4.6.4 GROIN PAIN - ELECTRODE PLACEMENT EXAMPLES .............................35
4.6.4.1 Placement for Groin Pain in One Location.....................................35
4.6.4.2 Placement for Groin Pain in Two Locations....................................35
4.6.4.3 Placement for Interstitial Cystitis ....................................................36
4.6.5 QUADRICEPS PAIN - ELECTRODE PLACEMENT EXAMPLES..................37
4.6.5.1 Placement for Quadriceps Pain in One Location...........................37
4.6.5.2 Placement for Quadriceps Pain Over a Large Area .......................38
4.6.6 HAMSTRING PAIN - ELECTRODE PLACEMENT EXAMPLES ...................39
4.6.6.1 Placement for Hamstring Pain in One Location.............................39
4.6.6.2 Placement for Hamstring Pain Over a Large Area .........................40
4.6.7 KNEE AND LOWER LEG PAIN - ELECTRODE PLACEMENT EXAMPLES..41
4.6.7.1 Placement for Central Knee Pain (for example from an
ACL Sprain, Bursitis or Osteoarthritis) ............................................41
4.6.7.2 Placement for Medial Knee Pain (for example from an
MCL Sprain, Pes Anserine Bursitis or Osteoarthritis) ......................42
4.6.7.3 Placement for Quadriceps Tendinitis .............................................43
4.6.7.4 Placement for Patellar Tendinitis ....................................................44
4.6.7.5 Placement for Lateral Knee Pain (for example from an
LCL Sprain, Bursitis or Osteoarthritis..............................................45
4.6.7.6 Placement for Illiotibial Band (IT Band) Pain..................................46
Table of Contents (continued)
(continued)

Biowave Corporation 3
Table of Contents (continued)
(continued)
4.6.7.7 Placement for Pain Throughout the Knee or for Pain in
2 Locations (for example from a Total Knee Replacement) ...........47
4.6.7.8 Placement for Posterior Knee Pain.................................................48
4.6.7.9 Placement for Pain from Shin Splints .............................................49
4.6.7.10 Placement for Calf Pain (for example from a Gastrocnemius Strain) . 50
4.6.8 ANKLE AND FOOT PAIN - ELECTRODE PLACEMENT EXAMPLES........51
4.6.8.1 Placement for Lateral Ankle or Foot Pain
(for example from a Low Ankle or Foot Sprain) .............................51
4.6.8.2 Placement for High Ankle Sprain with only a Primary Pain Site......52
4.6.8.3 Placement for Foot or Ankle Injury with Pain in 2 Locations..............53
4.6.8.4 Placement for Achilles Tendinitis....................................................54
4.6.8.5 Placement for Medial Ankle or Foot Pain ......................................55
4.6.8.6 Placement for Plantar Fasciitis........................................................56
4.6.8.7 Placement for Pain on Top of the Foot (for example from
Phalange, Metatarsal, Neuroma or Turf Toe Pain) .........................57
4.6.9 NECK AND CERVICAL PAIN - ELECTRODE PLACEMENT EXAMPLES ...58
4.6.9.1 Placement for Neck or Cervical Pain in One Location ...................58
4.6.9.2 Placement for Neck or Cervical Pain in One Location with
Dispersive Radiating Pain...............................................................59
4.6.9.3 Placement for Neck or Cervical Pain Over a Large Area................60
4.6.9.4 Placement for Bilateral Neck or Cervical Pain ...............................60
4.6.9.5 Placement for Neck or Cervical Pain in 2 Locations ......................61
4.6.10 SHOULDER PAIN - ELECTRODE PLACEMENT EXAMPLES......................62
4.6.10.1 Placement for Pain in the Acromioclavicular (AC) Joint or
for Pain Inside the Shoulder Joint (e.g. Frozen Shoulder) ............
62
4.6.10.2 Placement for Anterior Shoulder Pain (for example from
Biceps Tendinitis, Supraspinatus Tendinitis or a Superior Labrum
Anterior to Posterior (SLAP) Tear) ........................................................ 63
4.6.10.3 Placement for Posterior Shoulder Pain (for example from an
Infraspinatus Strain or Posterior Rotator Cuff Tendinitis) ................ 64
4.6.10.4 Placement for Sternoclavicular (SC) Pain
(for example from an SC Sprain) ......................................................... 65
4.6.10.5 Placement for Pain on the Edge of the Shoulder
(for example from Rotator Cuff Tendinitis) ........................................ 66
4.6.10.6 Placement for Shoulder Pain on the Trapezius ................................ 67
4.6.10.7 Placement for 2 Locations of Pain in One Shoulder ....................... 67
4.6.10.8 Placement for Bilateral Shoulder Pain
(Pain in 2 Locations) ............................................................................. 68

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4.6.11 ELBOW PAIN - ELECTRODE PLACEMENT EXAMPLES ............................69
4.6.11.1 Placement for Lateral Elbow Pain
(for example, Lateral Epicondylitis)
.................................................... 69
4.6.11.2 Placement for Medial Elbow Pain
(for example, Medial Epicondylitis) ................................................... 70
4.6.11.3 Placement for Posterior Elbow Pain
(for example, Triceps Tendinitis) .......................................................... 71
4.6.12 WRIST, HAND & FINGER PAIN - ELECTRODE
PLACEMENT EXAMPLES .........................................................................72
4.6.12.1 Placement for Posterior or Anterior Wrist Pain ...........................
72
4.6.12.2 Placement for Pain from a Triangular Fibrocartilage Complex
(TFCC) Wrist Sprain...................................................................... 73
4.6.12.3 Placement for Hand or Finger Pain ............................................ 74
4.6.12.4 Alternative Placement for the Larger Rectangular Electrode
on Small Diameter Wrists............................................................. 75
4.7 Placing Biowave Noninvasive Electrodes................................................................76
4.8 Placing Biowave Percutaneous Electrodes .............................................................79
4.9 Turning on the BiowavePRO Neurostimulator........................................................79
4.10 Using the BiowavePRO Neurostimulator................................................................80
4.10.1 Starting Treatment......................................................................................80
4.10.2 During Treatment .......................................................................................81
4.10.3 End of Treatment........................................................................................81
4.11 Importance of Monitoring the Activity of the Neurostimulator..............................82
5. Treatment Regimen Protocols .......................................................................83
5.1
Treatment Regimen with Biowave Noninvasive Electrodes for Athletic Training........83
5.2 Treatment Regimen with Biowave Noninvasive Electrodes for
Physical Therapy and Postoperative Rehabilitation.....................................................84
5.3 Treatment Regimen with Biowave Percutaneous Electrodes
for Patients with Severe Chronic, Acute or Postoperative Pain..............................85
6. Battery Indicator, Charging and Replacing the Battery ..............................86
6.1 Battery Indicator......................................................................................................86
6.2 Charging the Battery...............................................................................................86
6.3 Replacing the Battery..............................................................................................87
7. Maintenance, Cleaning and Storage Instructions ........................................88
7.1 Maintenance, Cleaning and Storage Instructions...................................................88
7.2 Disposal of Waste Products ....................................................................................89
Table of Contents (continued)
(continued)

Biowave Corporation 5
8. Troubleshooting and Other Functions ..........................................................90
8.1 Troubleshooting Error Conditions on LCD Display ................................................90
8.1.1 Leadwire Connection to the Neurostimulator .............................................90
8.1.2 Electrode Connection to the Leadwire Cable .............................................90
8.1.3 Electrode Connection to the Patient ...........................................................91
8.1.3.1 Patient Has Lotion on Their Skin or Has Oily Skin..........................91
8.1.3.2 Electrode Has Lost Adhesion and Conductivity.............................91
8.1.3.3 Dry, Flaky Skin .................................................................................91
8.1.3.4 Excessive Hair on Skin.....................................................................92
8.1.3.5 Broken Connection Between Metal Connector and Gray Cord ....92
8.2 Other Troubleshooting Issues ..................................................................................93
8.2.1 Leadwire Cable is Unplugged During Treatment.........................................93
8.2.2 Electrode(s) Detach From Patient’s Body During Treatment........................93
8.2.3 Use of Non-Biowave Electrodes ...................................................................94
8.2.4 Muscle Twitching...........................................................................................94
8.2.5 Patient Quickly Reaches Maximum Intensity................................................94
8.2.5.1 Maximum Intensity Reached Due To High Skin Impedance ..........94
8.2.5.2 Maximum Intensity Reached Due To Postoperative
Loss of Proprioception....................................................................95
8.3 Automatic Safety Function .......................................................................................96
8.3.1 Intensity Decreases Automatically and/or Pressing Plus (+) Button
Will Not Increase Intensity............................................................................96
8.4 Other Functions........................................................................................................97
8.4.1 Change Treatment Time ...............................................................................97
8.4.2 Pause Treatment Mid-Procedure ..................................................................98
8.4.3 Change Contrast of LCD Display..................................................................98
9. Technical Specifications and Classifications..................................................99
9.1 Technical Specifications............................................................................................99
9.2 Classifications .........................................................................................................100
10. Contact Information and Warranty .............................................................106
10.1 Reorder Information and Technical Support........................................................106
10.2 Limited Warranty ..................................................................................................106
Notes ..................................................................................................................... 107
Table of Contents (continued)

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IMPORTANT!
Before using this product, read the
following information thoroughly.
Rx Only

Biowave Corporation 7
Neuromodulation is the electrical stimulation of a nerve for the relief of pain.
Biowave manufactures and sells two professional neuromodulation pain
therapy systems which utilize the BiowavePRO Neurostimulator:
The BiowavePRO System is comprised of a BiowavePRO®Neurostimulator
and Biowave Noninvasive Electrodes.
The BiowavePENS System is comprised of a BiowavePRO®Neurostimulator
and Biowave Percutaneous Electrodes.
Both the BiowavePRO and BiowavePENS Systems are indicated for:
• Symptomatic relief of chronic, intractable pain, post surgical and
post-traumatic acute pain
• Symptomatic relief of post-traumatic acute pain
• Symptomatic relief of post-operative pain
1. Indications for Use
See Section 4.6 for examples of electrode placements.
Neck and
Cervical Spine
Lower Back and
Lumbar Spine
Shoulder
AREAS OF TREATMENT
Wrist, Hand
and Fingers
Hip
Elbow
Knee
Ankle, Foot
and Toes
Biceps
Shoulder
Calf
Triceps
Quadriceps
Hamstring
Forearm
Mid Torso and
Thoracic Spine
IT Band
Groin
Buttock
Shin

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The BiowavePRO®Neurostimulator is a
medical device which utilizes a unique signal
mixing technology to deliver electrical signals
through skin to the surface of nociceptive
pain fibers for inhibiting pain transmission
and improving function.
The neurostimulator is comprised of a
plastic housing containing the electronics
and a rechargeable battery. On the face of
the neurostimulator is a large LCD display
showing signal intensity as a percent of
maximum intensity, the treatment time
selected, the remaining treatment time, a
battery indicator and error indications (for
example if the electrodes become disconnected
from the patient). A System Indicator Light
resides above the LCD display indicating the
operating condition of the neurostimulator.
There are 5 buttons that control the stimulator:
1. Power ON/OFF button
2. PLUS (+) button to increase intensity or increase treatment time
3. MINUS (–) button to decrease intensity or decrease treatment time
4. TIME button to enter TIME mode in order to change treatment time
5. OK button to accept and set a new treatment time
2. Neurostimulator Description
BiowavePRO®
Neurostimulator
1
2
3
45

Biowave Corporation 9
Plugging Single End of Leadwire Cable into BiowavePRO Neurostimulator
Plugging the Leadwire Cable into the Neurostimulator
When the connector plugs into the neurostimulator, the red dot on the metal
connector
should face upwards. The notch on the connector mates with the
keyhole in the opening on the neurostimulator and the connector gently
slides in and clicks in place (see photo above).
2. Neurostimulator Description
2.1 Neurostimulator Accessories
2.1.1 LEADWIRE CABLE
A “Y” shaped leadwire cable connects two disposable electrodes to the
BiowavePRO®Neurostimulator. The single end of the leadwire cable plugs
into the front of the neurostimulator as shown in the photo below.
Keyhole
Notch
Metal
Barrel

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Removing the Leadwire Cable from the Neurostimulator
To remove the leadwire cable, hold the Metal Barrel shown in the photo on
the prior page with the thumb and index finger and gently pull straight back
out of the neurostimulator. This will release the connector and it will slide
straight out.
NEVER twist the connector;
NEVER pull on the strain relief or on the cord when trying to remove the
leadwire cable from the neurostimulator.
Connecting the Leadwire Cable to Electrodes
BiowavePRO®uses two electrodes for a treatment. Either electrode can be
connected to either blue connector at the end of the leadwire cable (see
photo below).
Line up the leadwire cable and electrode connectors and plug them together
until they click in place. When connected together, the electrode connector
will partially stick out from the leadwire cable connector allowing an easy grip
when pulling them apart.
Leadwire Cable and
Electrode Connectors
Leadwire Cable
Connectors
Electrode
Connectors

Biowave Corporation 11
2. Neurostimulator Description
Removing the Electrodes from the Leadwire Cable
To remove the electrodes from the leadwire cable, grasp each side of the blue
connector with your thumb and index finger and pull them straight apart.
2.1.2 AC CHARGER
The Universal AC Charger is only used to
recharge the battery in the neurostimulator.
The cord from the AC Charger is plugged into
the neurostimulator. A larger power cord is
plugged into the other end of the AC Charger
and into a standard electrical outlet (110-240
Volts, 50-60 Hz).
The leadwire cable must first be unplugged in
order to allow room for the AC Charger to be
plugged into the neurostimulator.
Leadwire Cable
Plugs in Here
AC Charger
Plugs in Here

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2.2 Electrodes
There are two types of Biowave Electrodes designed to work with the
BiowavePRO Neurostimulator: Biowave Noninvasive Electrodes and
Biowave Percutaneous Electrodes. When the neurostimulator is combined
with noninvasive electrodes, the system is called BiowavePRO; when the
neurostimulator is combined with percutaneous electrodes, the system is
called BiowavePENS.
Biowave Noninvasive Reusable Electrodes
Biowave®Noninvasive Electrodes are reusable surface electrodes typically used
to reduce pain and facilitate physical therapy in professional and
college sports, in physical and occupational therapy and chiropractic settings.
The BiowavePRO®Neurostimulator when used in conjunction with Biowave
Noninvasive Electrodes is called BiowavePRO®and is FDA cleared as a
Neuromodulation Pain Therapy System.
Biowave Percutaneous Electrodes
Biowave®Percutaneous Electrodes utilize a patented technology involving
an array of over 1000 needles to significantly facilitate the delivery of the
BiowavePRO Neurostimulator’s therapeutic signals through the skin, directly
to the surface of nociceptive pain fibers. The BiowavePRO Neurostimulator
when used in conjunction with Biowave Percutaneous Electrodes is called
BiowavePENS®and is FDA cleared as Percutaneous Electrical Nerve Stimulation.
Biowave®Percutaneous Electrodes are sterile, single-use electrodes, and
are used under the supervision of a physician typically in a pain or spine
clinic, hospital or physician office setting to reduce severe chronic, acute or
postoperative pain.
Warning
ELECTRODES MUST NEVER TOUCH EACH OTHER
• 1.0 inch is the minimum spacing between
electrodes on the back
• 0.5 inches is the minimum spacing between
electrodes on joints or extremities
• There is NO maximum spacing between any electrodes

Biowave Corporation 13
2. Neurostimulator Description
B-Set: Two round equal area electrodes
(2 inch diameter) for treating two locations of
pain. Used for treating:
• bilateral or unilateral pain in the low back
and buttocks
• bilateral pain in the cervical spine or shoulders
• radiculopathies
• pain in two locations in the hip or groin
• pain centered directly over the spine
• pain throughout the knee or shoulder
• pain over large areas
E-Set: One small round electrode for a single
location of pain (1.375 inch diameter); and
one rectangular dispersive electrode (2 inch x
4 inch) to be placed in a comfortable location
to receive stimulation - typically over a bony
prominence near the region being treated.
Used for treating single locations of pain in
the extremities including:
• knee, ankle, foot, toe
• neck, shoulder, elbow, wrist, hand, finger
U-Set: One round electrode for a single
location of pain (2 inch diameter); and one
large rectangular dispersive electrode (5 inch
x 8 inch) to be placed horizontally across
the lumbar region on the lower back - a
convenient comfortable location. Used for
treating a single location of pain in the mid-
torso region including:
• rib, oblique, hip, groin
• buttock, gluteus maximus, adductor, abductor
• hamstring, quadriceps
EBWEN02-E
2.2.1 BIOWAVE NONINVASIVE REUSABLE ELECTRODES
There are three different sized sets of Biowave®Noninvasive Electrodes for
focusing the therapeutic signals to different locations in the body:
BWEN03-U
U
BWEN01-B
B

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2.2.2 BIOWAVE PERCUTANEOUS ELECTRODES
There are two different sized sets of Biowave®Percutaneous Electrodes for
focusing the therapeutic signals to different locations in the body:
B-Set: Two round same area Percutaneous
Electrodes (2.5 inch diameter) are placed
over two equal locations of pain, or over one
location of pain and over the source or origin
of the pain. Used for treating:
• bilateral pain in the low back and
buttocks
• bilateral pain in the thoracic or cervical
spine and shoulders
• pain of equal magnitude in two locations
• radiculopathies
• pain centered directly over the spine
• pain throughout the knee or shoulder
• pain over large areas
E-Set: One round Percutaneous Electrode
(2.5 inch diameter) is placed over a single
location of pain; and one rectangular
noninvasive electrode (2 inch x 4 inch) is
placed over a comfortable location to receive
stimulation - typically a bony prominence near
the region being treated. Used for treating
single locations of pain including:
• unilateral pain in the extremities
including the knees, ankles, feet, toes,
neck, shoulders, elbows, wrists, hands
and fingers
• unilateral pain including, single points
of pain (up to 3 inches in diameter) in
the lumbar, thoracic or cervical area of
the back, ribs, obliques, hips, buttocks,
groin or gluteus maximus
BWEP01-B
B
EBWEP02-E

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2. Neurostimulator Description
2.3 Neurostimulator Controls
2.3.1 POWER BUTTON
The Power Button is located on the right side of the stimulator.
Pressing the Power Button once and holding it down for about
one second until the screen lights up, turns the neurostimulator
on. While the neurostimulator is on, pressing the Power
Button once pauses operation of the neurostimulator.
Holding the button down for two seconds or more while the
neurostimulator is on, turns the neurostimulator off.
The power should be turned on AFTER the leadwire is cable is connected on
both ends and the electrodes are attached to the patient. Once the power
is turned on, the LCD display should read 0.0% and the patient can begin
pressing the PLUS (+) Button to increase intensity beginning the treatment.
2.3.2 PLUS BUTTON (+)
Pressing the PLUS (+) Button increases the intensity of
the signal and the level of the tingling/pressure sensation
felt by the patient. The PLUS (+) Button is also used to
increase treatment time, after the TIME button is pressed.
2.3.3 MINUS BUTTON (–)
Pressing the MINUS (–) Button decreases the intensity of the
signal and the level of the tingling/pressure sensation felt by
the patient. The MINUS (–) Button is also used to decrease
the treatment time, after the TIME button is pressed.
2.3.4 TIME BUTTON AND OK BUTTON
The treatment time is set to a default of 30 minutes. Pressing the TIME
button allows the user to change the treatment time either before or during
a treatment. After pressing the TIME Button, pressing the PLUS (+) Button
or MINUS (–) Button increases or decreases the treatment time in 1-minute
increments. The treatment time can be set from 5 to 60 minutes. After selecting
the desired treatment time, pressing the OK button sets the treatment time.
Power
Button
PLUS, MINUS, TIME
and OK buttons

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2.4 Neurostimulator Indicators
2.4.1 LCD DISPLAY
The LCD display on the front of the stimulator provides treatment information:
• Signal Intensity as a percent of maximum
intensity, is indicated by the largest number
in the middle of the display. At the beginning
of a treatment the intensity should read 0.0%
on the LCD display.
• Total Treatment Time is indicated on the lower left corner of the display
• Remaining Treatment Time is indicated on the lower middle of the display
• Battery Strength Indicator is indicated on the lower right corner of
the display
• Problems - if a problem occurs, a picture will
appear in the center of the display showing
the action to correct the problem. For
example if one or both electrodes become
detached from the patient, the intensity will
go to zero (0.0%), the treatment time will pause and a picture will appear
showing that the electrodes should be placed back onto the patient’s body
(see Section 8 - Troubleshooting and Other Functions).

Biowave Corporation 17
2. Neurostimulator Description
System Indicator Light
2.4.2 SYSTEM INDICATOR LIGHT
A single System Indicator Light is located above
the LCD display on the neurostimulator. This
Indicator Light shows the status of the treatment
of the neurostimulator.
The Indicator Light remains solid GREEN during
a treatment, begins flashing GREEN with 5 minutes
left and turns solid YELLOW at the end of the treatment.
The Indicator Light will flash GREEN while the battery is charging. The Indicator
Light will flash YELLOW when there is an Error Condition or Problem (see
Section 8 - Troubleshooting and Other Functions).